BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 LAT COXA VARA SIZE 14

    MDR report key: 3943239 · Received July 18, 2014

    Report

    Report Number
    1818910-2014-23699
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    LZO
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES AND PATIENT RADIOGRAPHY CONFIRM THE REPORTED FRACTURE OF THE FEMORAL STEM AT THE NECK. THE FEMORAL HEAD REMAINS ATTACHED AT THE TAPER OF THE FEMORAL STEM. NO UNEVEN WEAR IS NOTED ON THE ARTICULATING SURFACE OF THE FEMORAL HEAD. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE FEMORAL STEM PRODUCT/LOT CODE COMBINATION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. VISUAL OBSERVATION OF THE FRACTURE SURFACES SHOWS HIGH DAMAGE, WHICH HAS POSSIBLY OCCURRED AFTER THE FAILURE OF THE FEMORAL STEM; FAILURE MECHANISM CANNOT BE CONFIRMED AS THE INITIATION SITE OF THE FRACTURE IS NOT VISIBLE ON EITHER HALVES OF THE FEMORAL STEM. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED EVENT IS UNDETERMINED AND NO CORRECTIVE ACTION HAS BEEN INDICATED. MONITOR THROUGH TRENDING VIA (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S MEDICAL RECORDS WERE REVIEWED. THE PATIENT WAS REVISED TO ADDRESS A BROKEN CORAIL STEM IN THE NECK REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421427 CORAIL2 LAT COXA VARA SIZE 14 HIP FEMORAL STEM/SLEEVE LZO DEPUY FRANCE SAS 3003895575 2623245

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention